Upper body convective heat therapy device and method of making and using same

ABSTRACT

A therapy device for providing heated air to the upper body of a patient and a method of making and using the therapy device have been provided. The therapy device is an inflatable U-shaped tube mounted on a base sheet and having a cover sheet. The patient is placed on the base sheet with the patient&#39;s head located between the legs of the tube. The cover sheet is placed over the patient&#39;s face. A heated air supply tube is connected to the tube and the heated air inflates the tube and heated air is forced out of the exhaust ports of the tube, thereby providing an environment in which a portion of the patient&#39;s body is heated. In one embodiment the exhaust ports are slits cut into the tube sheet material, and the slits are parallel to a tangent line of the tube&#39;s sealed edge. The method of fabricating the therapy device includes forming the individual pieces, attaching the tube sheets to form a tube, lancing the tube to form exhaust ports, and attaching the remaining pieces. In another embodiment, the exhaust ports are formed by selectively coating the tube sheets with an air impermeable material except for an area bounded by the exhaust ports.

CROSS-REFERENCE TO RELATED APPLICATIONS

Not Applicable

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT

Not Applicable

BACKGROUND OF THE INVENTION

1. Field of Invention

This invention relates to the field of heat therapy. More specifically,the present invention relates to a disposable hypothermia article foruse with a heat source to supply a source of controlled temperature airto a patient's upper body surface.

2. Description of the Related Art

During and after a surgical procedure, it is well known that the loss ofbody temperature by the patient can lead to hypothermia. Accordingly, itis well known to apply heat to the patient in order to replace the heatthat is lost. While heat loss associated with surgery is discussedherein, it is well known that hypothermia is also caused by othercircumstances, such as prolonged exposure to extreme cold. No matterwhat the cause of hypothermia, it is essential to apply heat to thepatient in order to either prevent or overcome hypothermia.

One method for applying heat to a patient is by directing warm airtoward the patient. Of specific interest is a generally U-shaped hollowtubular member through which heated air is supplied. Typical of the artare those devices disclosed is U.S. Pat. No. 5,165,400, titled“Convective Hyperthermia Article,” issued to Berke on Nov. 24, 1992; andU.S. Pat. No. 5,300,101, titled “Method and Apparatus for Treatment ofPediatric Hypothermia,” issued to Augustine, et al., on Apr. 5, 1994.

The '400 device disclosed by Berke is a U-shaped device having twosubstantially parallel legs positioned adjacent to and extending asubstantial length of a patient's body, and the device directs heatedair to the body. The '400 device has a crosspiece connecting the twolegs. The '101 device disclosed by Augustine is a device similar to thatdisclosed in the '400 patent, except that it fits an infant or smallchild and includes positionable covering sheets.

It is an objective of this invention to provide a heat therapy devicefor a patient who is off-pump. It is a further objective to provide atherapy device for the upper body, specifically the head and uppershoulders.

BRIEF SUMMARY OF THE INVENTION

According to one embodiment of the present invention, an upper bodyconvective heat therapy device is provided. The heat therapy device is alight weight disposable convective hypothermia article that provideswarm air to a patient's upper body. It is suitable for use in off-pumpsituations; that is, when the patient is not on life-support, butrequires a source of heat.

In one embodiment, the therapy device is a U-shaped tube that isinflated with a heated air supply. The heated air escapes through slitsor an air permeable portion of the tube and is directed towards thepatient's head and shoulders. The tube is attached to a flat sheet, uponwhich the patient lies. Attached to the tube is a flat covering sheetthat can be positioned over the patient's upper body without restrictingaccess to the patient. The covering sheet forms a tent over the patientand serves to prevent the heated air from escaping. The covering sheetis fabricated of a clear material that permits viewing the face of thepatient.

A method of making the therapy device includes cutting or forming tubesheets, gluing or welding them together, forming exhaust ports in theresulting tube, attaching the tube to a base sheet and a cover sheet. Amethod for selectively warming a patient's upper body is disclosed andincludes arranging a therapy device around the patient's head andshoulders, forcing heated air into the device, exhausting air from thedevice and directing the air to the patient. A cover sheet is used toprevent the heated air from immediately escaping.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

The above-mentioned features of the invention will become more clearlyunderstood from the following detailed description of the invention readtogether with the drawings in which:

FIG. 1 is a top view of a patient with the therapy device inflated andin place;

FIG. 2 is a perspective view of the therapy device;

FIG. 3 is a top view of the therapy device;

FIG. 4 is a top view of another embodiment of the therapy device;

FIG. 5 is an exploded view of the therapy device;

FIG. 6 is a perspective view of one panel of one embodiment the device;

FIG. 7 is a perspective view of the embodiment illustrated in FIG. 6;and

FIG. 8 is a block diagram showing the steps of fabricating oneembodiment of the therapy device.

DETAILED DESCRIPTION OF THE INVENTION

An apparatus for an upper body convective heat therapy device 10 and amethod of making and using the device 10 is disclosed. Referring to FIG.1, the therapy device 10 provides warm air to the upper portion of apatient's body 110. A base sheet 104 is placed under the head andshoulders of the patient 110, who is lying on a table or bed 114. Thetherapy device 10 is connected to a supply hose 112 from a heated airsupply (not illustrated). When air is pumped into the therapy device 10,the tube 102 inflates, and heated air is exhausted in a thermal warmingzone surrounding a portion of the patient's body 110. A cover sheet 106prevents the heated air from immediately escaping and is attached 107 toone leg of the tube 102. The cover sheet 106 is positioned over the headof the patient 110 and placed on top of the tube 102.

FIG. 2 illustrates a perspective view of an inflated therapy device 10.A first securing strap 206 extending from the seam 222 on the inside ofthe tube 102 is attached to the base sheet 104. A second securing strap306 (not illustrated in FIG. 2) extends similarly from the seam oppositethat of the first securing strap 206. The securing straps 206, 306 areattached to the base sheet 104 by any of various methods known by thoseskilled in the art, including welding, double-sided tape, or hot-glue.

The cover sheet 106 is a clear plastic material that forms a tent overthe head of the patient 110 and serves to direct the escaping air over agreater portion of the body of the patient 110 by preventing theimmediate escape of the heated air. A portion of one end 107 of thecover sheet 106 is attached 107 to one leg of the tube 102 using meansknown to those skilled in the art, for example, welding, double-sidedtape, or hot-glue.

Also shown in FIG. 2 are the exhaust ports or slits 212 a, 212 b, 212 c,212 d through which the heated air forced into the therapy device 10escapes. The slits 212 are substantially parallel to a line tangent tothe nearest seam edge of the tube 102. Alternatively, the slits 212 aresubstantially perpendicular to the tangent of a circumference of thetube 102 defined by a radius perpendicular to the axis of the tube 102.In another embodiment, the exhaust ports 212 are V-shaped slits; thatis, each exhaust port 212 is formed of two slits that are connected atone end and separated at the other end. In still another embodiment, theexhaust ports 212 are holes cut or punched into the tube 102.

In yet another embodiment, the exhaust ports 212 are an integral part ofthe fabric of the tube 102. That is, the tube 102 is fabricated withmaterial that is air impermeable in all areas except where the exhaustports 212 are located. For example, the tube 102 is fabricated out ofair permeable fabric that is coated with a thin sheet of plastic orother air impermeable material. The coating completely coats the tube102 material except in the areas in which heated air is to be exhausted.The uncoated areas form the exhaust ports 212 because air escapes fromthe tube 102 in those areas. Those skilled in the art will recognizethat size, number, and location of the exhaust ports 212 can varydepending on the available air flow without departing from the spiritand scope of the present invention.

The exhaust ports 212 cover the surface of the tube 102 in the area inwhich heated air is desired to be exhausted. In the illustratedembodiment, the tube 102 does not discharge heated air in the area wherethe patient's ears would be located. The area between exhaust ports 212a and 212 b, 212 c and 212 d is the area of the tube 102 that isadjacent to the ears of the patient 110.

FIG. 3 shows a therapy device 10 in a deflated state. The legs 302, 304of the therapy device 10 are splayed out because, when the tube 102 isinflated, the end of the legs 302, 304 draw towards each other. In theillustrated embodiment, the legs 302, 304 are substantially parallel toeach other when the therapy device 10 is inflated.

FIG. 4 shows another embodiment of a therapy device 10′ in a deflatedstate. In this embodiment, the legs 402, 404 of the therapy device 10′have a foot-shaped end portion opposite their connection to thecrosspiece 308. The shape of the legs 402, 404 permits the heated airexhausted from the therapy device 10′ to be directed across the top ofthe full width of the shoulders of the patient 110.

FIG. 5 is an exploded view of the therapy device 10, showing the basesheet 104, two tube sheets 502, 504, the cover sheet 106, and the inletcollar 108. The base sheet 104 is fabricated of the same material as thetube sheets 502, 504, although those skilled in the art will recognizethat other material can be used without departing from the spirit andscope of the present invention. The cover sheet 106 is fabricated of athin-gauge clear plastic that is impermeable to air, for example, 10gauge clear PVC sheeting.

The tube 102 is made of two tube sheets 502, 504, one on top of theother. The tube sheets 502, 504 are fabricated of a material that is notpermeable to air, such as a fabric coated with a plastic. Those skilledin the art will recognize that any of various materials can be usedwithout departing from the spirit and scope of the present invention.Common materials include woven and non-woven fabrics and cellulosics.Material that is air permeable can be coated on at least one side with athin film of plastic or other air impermeable material. The material iswaterproof and impermeable to air.

In the illustrated embodiment, at least one of the tube sheets 502, 504has two securing straps 206, 306, each extending from a leg 206, 306towards the other. In another embodiment, the securing straps 206, 306are separate pieces of material placed between and secured to the tubesheets 502, 504. The two tube sheets 504, 504 are sealed together attheir common edges 222. The sheets 502, 504 can be sealed by gluing theopposing surfaces or by welding the plastic coated surfaces. The sealededge 222 extends into the tube sheet 502, 504 a distance sufficient toprovide an air tight seal and provide mechanical strength when the tube102 is inflated. For fabric with a plastic film, the sealed distance isapproximately one-quarter inch.

In the illustrated embodiment, the tube 102 is secured to the base sheet104 in four places. The tube 102 is attached by securing the seam 222 onboth sides of the inlet collar 108 to the base sheet 104. The tube 102can be glued or welded to the base sheet 104. The tube 102 is secured tothe base sheet 104 by the two securing tabs 206, 306 protruding from thetube 102. Each securing tab 206, 306 is folded under its respective tubeleg 302, 304 and secured to the base sheet 104.

The inlet collar 108 is secured to the cross-piece of the tube 102. Theinlet collar 108 is a section of stiff material, such as paper orcardboard, with a hole in the center sized to accept the nozzle of theheated air supply hose 112. The inlet collar 108 is attached to the tubesheets 502, 504 by gluing it to the fabric. Slits 512, 514 are cut intothe tube sheets 502, 504 and provide clearance for the nozzle of theheated air supply hose 112. In the illustrated embodiment, the inletcollar 108 is not secured to the base sheet 104.

FIG. 6 illustrates a tube sheet 602 for another embodiment of thepresent invention, which is illustrated in FIG. 7. The tube sheet 602,instead of being laid flat during fabrication, has excess material 604,606 which is folded over along the length of each leg 302, 304. Afterthe tube sheet 602 is attached to its mating tube sheet 504, the tubelegs 702, 704 have a greater height than without using the excessmaterial 604, 606. The excess material 604, 606 at the end of the tubelegs 702, 704 can be seen in FIG. 7 as a puckered area 712, 714 at theseam 222. As can be seen in FIG. 7, with the upper tube sheet 602 havingexcess material 604, 606, the seam 222 on the outside of the tube legs702, 704 is positioned closer to the base sheet 104 at the end of thetube leg 702, 704 opposite the connection to the crosspiece 708. Inanother embodiment, both the top and bottom tube sheets 502, 504 aresimilar to the tube sheet 602 with excess material 604, 606. A tubefabricated with excess material 604, 606 on both the top and bottom tubesheet 502, 504 has legs 702, 704 with a greater height, which results inthe cover sheet 106 being supported more by the tube legs 702, 704 thanthe face of the patient 110.

FIG. 8 is a flow diagram showing the steps of fabricating the therapydevice 10. The first step is to cut the material 802. Once the materialis cut, the tube sheets 502, 504 can be sealed at their common edges 222by welding 804 or other means for making an air tight seal.

In the illustrated embodiment, the exhaust ports 212 are slits cutparallel to a tangent line of the tube sheet 502, 504 edge 222. Once thetwo tube sheets 502, 504 are fastened together, the exhaust ports 212are formed 806 by cutting into the material of the tube 102. The exhaustports 212 can be cut 806 by lancing slits or punching holes in the tubesheets 502, 504. In another embodiment, the exhaust ports 212 areuncoated areas of an air permeable material that is partially coatedwith a thin film of plastic or other air impermeable material. For thisembodiment, when the tube sheet 502, 504 material is coated beforecutting, the exhaust ports 212 can be formed 806 before the material iscut. Those skilled in the art will recognize that the number of exhaustports 212 can vary based on their size and the available air supply flowwithout departing from the spirit and scope of the present invention.

After the tube sheets 502, 504 are mated 804, the tube 102 is secured tothe base sheet 104 by attaching the crosspiece 308 of the tube 102 tothe base sheet 104 and by attaching the securing straps 206, 306 to thebase sheet 104. The inlet collar 108 is secured 810 to the tube 102 andthe cover sheet 106 is attached 812 to the tube 102. Lastly, theassembled therapy device is folded and packed 814, and otherwise madeready for shipment, storage, and use.

In the illustrated embodiment, the patient 110 is positioned on the basesheet 104 with the head of the patient 110 between the legs 302, 304 ofthe therapy device 10. Heated air is pumped into the therapy device 10and is exhausted from the exhaust ports 212, which are of a size andnumber to maintain a back pressure in the therapy device 10, whichserves to keep the tube 102 inflated. The cover sheet 106 is extendedfrom one tube leg 302, over the face of the patient 110, and to theother tube leg 304. The therapy device 10 disclosed is suitable for usewith a patient 110 off-pump.

From the forgoing description, it will be recognized by those skilled inthe art that a therapy device for providing heated air to the upper bodyof a patient and a method of making the therapy device have beenprovided. The therapy device is an inflatable U-shaped tube mounted on abase sheet and having a cover sheet. The patient is placed on the basesheet with the patient's head between the legs of the tube. The coversheet is placed over the patient's face. A heated air supply tube isconnected to the tube and the heated air both inflates the tube and isforced out of the exhaust ports of the tube, thereby providing anenvironment in which a portion of the patient's body is heated.

While the present invention has been illustrated by description ofseveral embodiments and while the illustrative embodiments have beendescribed in considerable detail, it is not the intention of theapplicant to restrict or in any way limit the scope of the appendedclaims to such detail. Additional advantages and modifications willreadily appear to those skilled in the art. The invention in its broaderaspects is therefore not limited to the specific details, representativeapparatus and methods, and illustrative examples shown and described.Accordingly, departures may be made from such details without departingfrom the spirit or scope of applicant's general inventive concept.

Having thus described the aforementioned invention, we claim:
 1. Atherapy device for providing air to a patient's upper body, said devicecomprising: a tube having a first leg, a second leg, and a crosspiece,said tube having an orifice for an air supply hose, said tube having aplurality of exhaust ports, said tube having a first tube sheet and asecond tube sheet joined at a common outside edge, said first tube sheethaving said air permeable portion and an air impermeable portion, saidair impermeable portion formed by a coating of an air impermeablematerial applied to a portion of said first tube sheet, said pluralityof exhaust ports defined by an air permeable portion of said tube; abase sheet attached to said crosspiece; and a cover sheet attached tosaid first leg and extending to said second leg.
 2. A therapy device forproviding air to a patient's upper body, said device comprising: a tubehaving a first leg, a second leg, and a crosspiece, wherein said firstleg, said second leg, and said crosspiece defining a U-shaped opening,said tube having an orifice for an air supply hose, said tube formed byoverlaying a first tube sheet and a second tube sheet and joining saidfirst tube sheet and said second tube sheet at a common outside edge; aplurality of exhaust ports formed in said tube, said tube having an airpermeable portion and an air impermeable portion, said plurality ofexhaust ports defined by said air permeable portion of said tube,wherein said air impermeable portion is formed by a coating of an airimpermeable material applied to said tube; a base sheet attached to saidcrosspiece; at least one securing tab extending from said common outsideedge and attached to said base sheet; and a cover sheet attached to saidfirst leg, said cover sheet being transparent and extending to saidsecond leg.
 3. A therapy device for providing air to a patient's upperbody, said device comprising: a tube having a first leg, a second leg,and a crosspiece, said tube having an orifice for an air supply hose,said tube having a plurality of exhaust ports; a base sheet attached tosaid crosspiece, whereby said base sheet holds said tube in a fixedposition when inflating and deflating said tube; at least one securingtab extending from said first leg and attached to said base sheet; and acover sheet attached to said first leg and extending to said second leg,said tube positioned between said cover sheet and said base sheet.
 4. Atherapy device for providing air to a patient's upper body, said devicecomprising: a tube having a first leg, a second leg, and a crosspiece,said tube having an orifice for an air supply hose, said tube having aplurality of exhaust ports, said plurality of exhaust ports defined byan air permeable portion of said tube, said tube including a first tubesheet and a second tube sheet, said tube formed by overlaying said firsttube sheet and said second tube sheet and joining said first tube sheetand said second tube sheet at a common outside edge, said first tubesheet having said air permeable portion and an air impermeable portion,said air impermeable portion formed by a coating of an air impermeablematerial applied to a portion of said first tube sheet; a base sheetattached to said crosspiece, whereby said base sheet holds said tube ina fixed position when inflating and deflating said tube; and a coversheet attached to said first leg and extending to said second leg, saidtube positioned between said cover sheet and said base sheet.
 5. Atherapy device for providing air to a patient's upper body, said devicecomprising: a tube having a first leg, a second leg, and a crosspiece,wherein said first leg, said second leg, and said crosspiece defining aU-shaped opening, said tube having an orifice for an air supply hose,said tube formed by overlaying a first tube sheet and a second tubesheet and joining said first tube sheet and said second tube sheet at acommon outside edge, said tube having an air permeable portion and anair impermeable portion, said plurality of exhaust ports defined by saidair permeable portion of said tube, wherein said air impermeable portionis formed by a coating of an air impermeable material applied to saidtube; a plurality of exhaust ports formed in said tube; a base sheetattached to said crosspiece, whereby said base sheet holds said tube ina fixed position when inflating and deflating said tube; at least onesecuring tab extending from said common outside edge and attached tosaid base sheet; and a cover sheet attached to said first leg, saidcover sheet being transparent and extending to said second leg, saidtube positioned between said cover sheet and said base sheet.
 6. Amethod for fabricating a therapy device for providing heated air to apatient's upper body, said method comprising the steps of: (a) forming afirst tube sheet and a second tube sheet with a complementary shape,said complementary shape being generally U-shaped and having a firstleg, a second leg, and a crosspiece; (b) attaching said first tube sheetto said second tube sheet at an outside common edge such that said firsttube sheet and second tube sheet form a tube when inflated; (c) formingexhaust ports in said first tube sheet and said second tube sheet, saidstep of forming exhaust ports includes selectively coating said firsttube sheet with an air impervious material, wherein said first tubesheet is an air permeable material; (d) attaching said first tube sheetand said second tube sheet to a base sheet; (e) attaching a cover sheetto said first tube sheet, said cover sheet being attached by fixing oneend of said cover sheet to said first leg, said cover sheet extending tosaid second leg.